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Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 7 approach to manage new technical requirements from the health authorities. There is no one-size-fits-all operating model. A company might consider any of the following: • An umbrella model where headquarters determines the technology and processes and is responsible for coordinating efforts across regions • A collaborative model that encourages information to f low from headquarters to affiliates and back • A dispersed model, where affiliates hold responsibility for maintaining products in their region. Irrespective of the model, local teams may not have the resources to manage the workload involved with managing mature products, or they may lack the expertise to navigate complex safety and quality requirements. Technology and process limitations also represent a challenge for affiliate offices, for example, not having the technology or expertise to make use of automation to streamline processes or not knowing best practices for mitigating risk. By outsourcing the maintenance and strategic manage- ment of mature portfolios, pharmaceutical companies can achieve better collaboration across cross-functional teams and elevate the organization so there is better coordination and further optimization of business processes. Another key consideration is the need to respond to changing regulatory expectations. A key example is the move within the European Medicines Agency (EMA) away from documents and toward data and digital systems. In future, when submitting variations to a marketed product, companies will need to ensure the product datasets in the substance, product, organization, and referential (SPOR) database are correct and complete. Such changes will re- quire operational agility to ensure quality and compliance requirements are met to safeguard products on the market. For companies that have a decentralized approach to portfolio maintenance, there is a risk that disparate func- tions and teams will manage their activities in an uncoor- dinated manner, which can result in fragmented data and documentation at different locations. All of this requires a large pool of skilled resources with knowledge of relevant regulations in different regions. By working with outsourcing partners that bring specialized expertise and a blended, tailored model, companies can take advantage of new and emerging technologies, better manage regulatory information, adapt to evolving global regulations, and respond quickly to data and documentation requirements. Such a model ensures information is centrally available and managed by the outsourcing partner, which is better able to adapt to new ways of working regionally and globally to meet changing regulatory requirements. Moving to the next frontier Companies choose to outsource for many different reasons. Under the new wave of mature product maintenance out- sourcing, triggers can include a desire to harmonize global processes, the need to cut costs or focus on more strategic activities, as well as the need for more extensive expertise in a local market. Outsourcing should always be managed through good planning, with built-in key performance indicators (KPIs) and anchored on a multi-tiered governance and oversight structure to ensure that there are checks and balances. It's advisable to have clearly defined roles and responsibilities for internal and external team members and a checklist for processes, as well as defined in-scope and out-of-scope ac- tivities. A foundational process assessment of the current state helps teams to keep track of developments. Encour- age shared ownership of processes and allow teams to start small and apply lessons learned as the engagement scales. Adopting the right technology to automate processes can help the business become more efficient. However, many efficiency gains companies can realize from outsourcing and developing more streamlined pro- cesses, without careful planning problems will inevitably arise. These issues can be alleviated through change man- agement processes to ensure minimal disruption to the busi- ness and an easier path to doing things more efficiently and quickly. It's also important to adopt KPIs and regularly track and report these to ensure agreed-upon deliverables and expectations can be met by both sides. Next-frontier outsourcing brings benefits, but as with any process change, there will always be challenges. Plan for hiccups from the outset, paying particular heed to early problems that arise due to lack of alignment and commu- nication uncertainty. Contin. on page 11 Figure 1. A holistic approach to mature product outsourcing. FIGURE IS COURTESY OF PHARMALEX